SOLICITATION NOTICE
68 -- Production of SGS-742 under cGMP Conditions
- Notice Date
- 1/20/2012
- Notice Type
- Presolicitation
- NAICS
- 424210
— Drugs and Druggists' Sundries Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- 2411107
- Archive Date
- 2/10/2012
- Point of Contact
- Hunter A. Tjugum, Phone: 3014358780
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a proposal. A solicitation document will not be issued and proposals will not be requested. The National Institute on Drug Abuse (NIDA), Station Support/Simplified Acquisitions (SS/SA) Branch, on behalf of the National Institute of Neurological Disorders and Stroke (NINDS), intends to negotiate and award a purchase order on a noncompetitive basis to IRIX PHARMACEUTICALS, INC. located at 101 Technology Pl, Florence, SC 29501, for the acquisition of up to 8KG of the experimental drug (3-Amino-propyl)-butyl-phosphinic acid (SGS 742) under cGMP conditions for the clinical trial in children suffering from succinic semialdehyde dehydrogenase (SSADH) deficiency disease. The mission of NINDS Clinical Epilepsy Section is to perform research to improve the treatment of people with intractable epilepsy. NINDS intends to continue clinical trials in treating patients with SSADH, which is a severe pediatric neurotransmitter disorder causing seizures, neurological deficits, and developmental delay. At present, there is no proven treatment for the disease, but studies in experimental animals have suggested that SGS-742 may be beneficial. Further, in previous clinical trials in patients with mild cognitive impairment, SGS-742 significantly improved attention, as well as working memory. Rights to use SGS-742 in the NINDS SSADH deficiency clinical trial have since been transferred to NIH from the previous rights holder. The trial itself will be a double-blind cross-over trial in which patients will receive active drug for one period and a placebo for the second period. Drug encapsulation and blinding will be performed with placebo supplied by the NIH Clinical Center Pharmacy. Irix Pharmaceuticals, Inc. is the only known source that can produce SGS-742 in sufficient quantities required by the NINDS research trial in cGMP conditions, which makes the drug suitable for use in human clinical trials. Any other manufacturers would have to undergo an independent evaluation to meet human clinical trial standards that would delay drug acquisition and trial initiation, thereby causing an adverse effect on the health of children with SSADH deficiency. This acquisition is being conducted under simplified acquisition procedures using FAR Part 12 and is exempt from the requirements of FAR Part 6, Competition Requirements. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing synopsis number 2411107, may be submitted to the NIDA SS/SA Branch electronically to the attention of Hunter A. Tjugum, at hunter.tjugum@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/2411107/listing.html)
- Record
- SN02658242-W 20120122/120120234457-ac274fc0f696425124fbce60cf91e754 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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